UV1 vaccine(Ultimovacs)

Ultimovacs' reduction in head count forms part of “activity level adjustments and operational prioritization” that should stretch out the company’s finances into the final quarter of 2025. Ultimovacs previously hinted at a dash to preserve cash following the failure of its cancer vaccine in a phase 2 trial. Now, the Norwegian biotech has revealed that 40% of staff will be jettisoned to keep the company afloat next year. Ultimovacs had been assessing the effect of adding UV1, a candidate designed to induce a T-cell response against an enzyme that is active in most cancer cells, to Bristol Myers Squibb’s checkpoint inhibitors Opdivo and Yervoy. But the long-awaited results in March revealed the study in melanoma failed to hit either the primary endpoint of progression-free survival or secondary endpoints like overall survival and objective response rate. In a presentation to investors this morning, execs confirmed that an analysis of the trial data “showed no subgroup data of significant relevance to proceed with the development of UV1 in this combination.” Ultimovacs isn’t giving up on UV1, however. The company is still hopeful for the FOCUS trial of a combo with Merck & Co.'s Keytruda in head and neck cancer, which is scheduled to read out in the third quarter, followed by the DOVACC study with AstraZeneca's Imfinzi and Lynparza in ovarian cancer in the first half of next year. Then there’s the LUNGVAC trial with Regeneron's Libtayo in non-small cell lung cancer, which is still enrolling patients. “Based on experience from development of other drugs, including checkpoint inhibitors, we must anticipate different readouts in different trials, hence our strategy is to go broad in multiple indications and combinations,” the company explained in the presentation. But, to make it that far, Ultimovacs has to make some big decisions now. The 40% reduction in head count forms part of “activity level adjustments and operational prioritization” that should stretch out the company’s finances into the final quarter of 2025. “We remain dedicated to our investigation of the potential impact of UV1 vaccine across several cancer indications and immunotherapy combinations, and we are prepared for both challenges and accomplishments along the way,” CEO Carlos de Sousa said in this morning’s release. “We anticipate potential growth catalysts both in 2024 and 2025.”

Ultimovac’s UV1 works by inducing T cell response against telomerase reverse transcriptase (hTERT) – a protein that provides the limitless self-renewal hallmark in cancer progression. Image Credit: CI Photos / Shutterstock. Ultimovacs has implemented cash-saving strategies, including a 40% workforce reduction, to extend its reserves into Q4 2025. The operational adjustments are expected to provide a cash runway beyond the anticipated top-line readout from the next two Phase II trials – the FOCUS trial in Q3 this year, and the DOVACC trial in H1 2025. The UV1 cancer vaccine development programme has suffered some setbacks. The company has reported topline data from two Phase II trials, NIPU and INITIUM, for the vaccine used in combination with PD1 inhibitors in two cancer indications, with both trials failing to meet primary endpoints. The Phase II NIPU trial (NCT04300244) evaluated UV1 in combination with Bristol Myers Squibb’s checkpoint inhibitors Opdivo (nivolumab) and Yervoy (ipilimumab) as a second-line treatment in mesothelioma patients. The study failed to meet its primary endpoint of progression-free survival (PFS). The Phase II INITIUM trial (NCT02275416) also evaluated the UV1, Opdivo and Yervoy combination but in patients with unresectable or metastatic malignant melanoma. The study also failed to meet primary endpoints, with the company deciding to stop pursuing the therapy in this indication. See Also: NIH team develops AI tool to predict cancer drug response SGN-1 by Guangzhou Huajin Pharmaceutical Technology for Peritoneal Cancer: Likelihood of Approval Despite this, Ultimovacs expects positive readouts from the next two trials. The Phase II FOCUS trial (NCT05075122) evaluates the combination treatment of UV1 vaccine with MSD’s Keytruda (pembrolizumab) as a first-line treatment in patients with PD-L1 positive head and neck squamous cell carcinoma. The combination has been successful in the Phase I trial (NCT03538314), with an observed 67% overall survival rate at a three-year follow-up. While the company expects positive data in Q3 this year, it is prepared to wait for data readout from the DUVACC trial before deciding on the fate of UV1 should the FOCUS trial fail, said Ultimovac’s CEO Carlos de Sousa in a business update webcast today. The Phase II DUVACC trial (NCT04742075) evaluates UV1 in combination with AstraZeneca’s checkpoint inhibitor Infinzi (duvalumab) and Lynparza (olaparib), a poly-ADP ribose polymerase (PARP) inhibitor, as a second line treatment in patients with BRCA negative ovarian cancer. The trial is currently recruiting patients, with 40% of the total expected enrolment completed as of Q4 2023. UV1 is also being evaluated in an investigator-led Phase II LUNGVAC trial (NCT05344209). The study investigates the combination therapy of UV1 and Sanofi and Regeneron’s Libtayo (cemiplimab) as a first-line therapy in patients with advanced or metastatic non-small cell lung cancer. The trial started recruitment in October 2022 and reached only 15% enrolment as of Q4 2023. The topline data from the trial is expected in H1 2026. GlobalData forecasts therapeutic cancer vaccines as the weakest immuno-oncology agent class with relatively low global sales of up to $4bn by 2028, compared to checkpoint modulators sales reaching $120bn by 2028. GlobalData is the parent company of Pharmaceutical Technology . Other cancer vaccines in development include Transgene and Japanese NEC Corporation’s cancer vaccine, TG4050 , for the treatment of head and neck cancers and ISA Pharmaceuticals’ cancer vaccine, ISA101b , for treating oropharyngeal cancer.